Isosorbide Dinitrate, Diluted EP Impurity C CAS 16051-77-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.16051-77-7
Molecular FormulaC6H9NO6
Molecular Weight191.14 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Isosorbide Dinitrate, Diluted EP Impurity C CAS 16051-77-7 chemical structure

Description

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

CATO supplies Isosorbide Dinitrate, Diluted EP Impurity C (CAS 16051-77-7), a pharmacopoeial impurity reference standard (molecular formula C6H9NO6, MW 191.14 g/mol) used for the identification and quantification of trace impurities in APIs.

Isosorbide Dinitrate, Diluted EP Impurity C (C6H9NO6) contains a carbohydrate-derived structure, an amide group. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC6H9NO6
Molecular Weight191.14 g/mol
AppearanceWhite to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1961
Nitrogen Atoms1

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